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Outcomes of androgen replacement therapy in adult male hypogonadism: recommendations from the Italian society of endocrinology.
J Endocrinol Invest. 2015 Jan; 38(1):103-12.JE

Abstract

OBJECTIVE

We developed clinical practice guidelines to assess the individual risk-benefit profile of androgen replacement therapy in adult male hypogonadism (HG), defined by the presence of specific signs and symptoms and serum testosterone (T) below 12 nmol/L.

PARTICIPANTS

The task force consisted of eight clinicians experienced in treating HG, selected by the Italian Society of Endocrinology (SIE). The authors received no corporate funding or remuneration.

CONSENSUS PROCESS

Consensus was guided by a systematic review of controlled trials conducted on men with a mean T < 12 nmol/L and by interactive discussions. The guidelines were reviewed and sequentially approved by the SIE Guidelines Commission and Executive Committee.

CONCLUSIONS

We recommend T supplementation (TS) for adult men with severely reduced T levels (T < 8 nmol/L) to improve body composition and sexual function. We suggest that TS be offered to subjects with T < 12 nmol/L to improve glycaemic control, lipid profile, sexual function, bone mineral density, muscle mass and depressive symptoms, once major contraindications have been ruled out. We suggest that lifestyle changes and other available interventions (e.g. for erectile dysfunction) be suggested prior to TS. We suggest that TS should be combined with currently available treatments for individuals at high risk for complications, such as those with osteoporosis and/or metabolic disorders. We recommend against using TS to improve cardiac outcome and limited mobility. We recommend against using TS in men with prostate cancer, unstable cardiovascular conditions or elevated haematocrit. The task force places a high value on the timely treatment of younger and middle-aged subjects to prevent the long-term consequences of hypoandrogenism.

Authors+Show Affiliations

Department of Experimental Medicine, Sapienza University of Rome, Rome, Italy.Department of Clinical and Molecular Sciences, Polytechnic University of Marche, Ancona, Italy.Department of Medical and Pediatric Sciences, University of Catania, Catania, Italy.Medical Department Endocrinology Unit, Maggiore-Bellaria Hospital, Bologna, Italy.Department of Medicine, University of Padua, Padua, Italy.Department of Life, Health and Environment Sciences, Andrology, and Epidemiology, University of L'Aquila, L'Aquila, Italy.Department of Biosciences, Metabolism and Neural Sciences, University of Modena and Reggio Emilia, Modena, Italy.Sexual Medicine and Andrology Unit, Department of Experimental and Clinical Biomedical Sciences, University of Florence, Viale Pieraccini 6, 50139, Firenze, Italy. m.maggi@dfc.unifi.it.

Pub Type(s)

Journal Article
Review
Systematic Review

Language

eng

PubMed ID

25384570

Citation

Isidori, A M., et al. "Outcomes of Androgen Replacement Therapy in Adult Male Hypogonadism: Recommendations From the Italian Society of Endocrinology." Journal of Endocrinological Investigation, vol. 38, no. 1, 2015, pp. 103-12.
Isidori AM, Balercia G, Calogero AE, et al. Outcomes of androgen replacement therapy in adult male hypogonadism: recommendations from the Italian society of endocrinology. J Endocrinol Invest. 2015;38(1):103-12.
Isidori, A. M., Balercia, G., Calogero, A. E., Corona, G., Ferlin, A., Francavilla, S., Santi, D., & Maggi, M. (2015). Outcomes of androgen replacement therapy in adult male hypogonadism: recommendations from the Italian society of endocrinology. Journal of Endocrinological Investigation, 38(1), 103-12. https://doi.org/10.1007/s40618-014-0155-9
Isidori AM, et al. Outcomes of Androgen Replacement Therapy in Adult Male Hypogonadism: Recommendations From the Italian Society of Endocrinology. J Endocrinol Invest. 2015;38(1):103-12. PubMed PMID: 25384570.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Outcomes of androgen replacement therapy in adult male hypogonadism: recommendations from the Italian society of endocrinology. AU - Isidori,A M, AU - Balercia,G, AU - Calogero,A E, AU - Corona,G, AU - Ferlin,A, AU - Francavilla,S, AU - Santi,D, AU - Maggi,M, Y1 - 2014/11/11/ PY - 2014/05/31/received PY - 2014/08/06/accepted PY - 2014/11/12/entrez PY - 2014/11/12/pubmed PY - 2016/6/28/medline SP - 103 EP - 12 JF - Journal of endocrinological investigation JO - J Endocrinol Invest VL - 38 IS - 1 N2 - OBJECTIVE: We developed clinical practice guidelines to assess the individual risk-benefit profile of androgen replacement therapy in adult male hypogonadism (HG), defined by the presence of specific signs and symptoms and serum testosterone (T) below 12 nmol/L. PARTICIPANTS: The task force consisted of eight clinicians experienced in treating HG, selected by the Italian Society of Endocrinology (SIE). The authors received no corporate funding or remuneration. CONSENSUS PROCESS: Consensus was guided by a systematic review of controlled trials conducted on men with a mean T < 12 nmol/L and by interactive discussions. The guidelines were reviewed and sequentially approved by the SIE Guidelines Commission and Executive Committee. CONCLUSIONS: We recommend T supplementation (TS) for adult men with severely reduced T levels (T < 8 nmol/L) to improve body composition and sexual function. We suggest that TS be offered to subjects with T < 12 nmol/L to improve glycaemic control, lipid profile, sexual function, bone mineral density, muscle mass and depressive symptoms, once major contraindications have been ruled out. We suggest that lifestyle changes and other available interventions (e.g. for erectile dysfunction) be suggested prior to TS. We suggest that TS should be combined with currently available treatments for individuals at high risk for complications, such as those with osteoporosis and/or metabolic disorders. We recommend against using TS to improve cardiac outcome and limited mobility. We recommend against using TS in men with prostate cancer, unstable cardiovascular conditions or elevated haematocrit. The task force places a high value on the timely treatment of younger and middle-aged subjects to prevent the long-term consequences of hypoandrogenism. SN - 1720-8386 UR - https://www.unboundmedicine.com/medline/citation/25384570/Outcomes_of_androgen_replacement_therapy_in_adult_male_hypogonadism:_recommendations_from_the_Italian_society_of_endocrinology_ L2 - https://link.springer.com/article/10.1007/s40618-014-0155-9 DB - PRIME DP - Unbound Medicine ER -